Replacing Canes With an Elasticated Orthotic-garment in Chronic Stroke Patients: The Influence on Gait and Balance. A Series of N-of-1 Trials
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- Technical University of Bern
- Enrollment
- 4
- Primary Endpoint
- Change in Functional Gait Assessment from baseline to post-Intervention (up to 28 weeks)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This study aims to investigate the effect of an elasticated orthotic garment "Thera Togs" on walking ability and balance in currently cane using chronic stroke subjects (minimum 6 months post stroke) using a series of N-of-1 Trials.
Detailed Description
Aim: To investigate the effect of replacing canes with an elasticated orthotic-garment on gait and balance in chronic stroke subjects. Design Experimental, multiple baseline N-of-1 series with an ABC design with randomised period duration. Participants Four cane using chronic stroke subjects. Interventions Phase A (9-12 weeks) usual cane-walking to establish baseline values; Phase B (9-19 weeks) intervention: orthotic-garment worn throughout the day with maximal cane reduction; Phase C (9-10 weeks) individually determined follow-up: either no walking-aid, orthotic-garment or cane. Weekly measurement of Outcome Measures for gait and balance function
Investigators
Clare Maguire
Principle Investigator
Technical University of Bern
Eligibility Criteria
Inclusion Criteria
- •Chronic stroke (\> six months since last stroke)
- •Independent cane walkers. Subjects usually use canes to walk inside (this could be intermittent changing from cane to holding furniture etc.) and always when outside
- •A Mini Mental Score of 22 or above.
Exclusion Criteria
- •Patients at risk of falling identified as a Berg Balance Score ≤42/56
Outcomes
Primary Outcomes
Change in Functional Gait Assessment from baseline to post-Intervention (up to 28 weeks)
Time Frame: Post intervention up to 28 weeks (on average 21.5 weeks)
Change of gait function between phases A (baseline) and Phase B (Intervention)
Secondary Outcomes
- Change in Trunk-sway from baseline to post-Intervention (up to 28 weeks)(Post intervention up to 28 weeks (on average 21.5 weeks))